Data / Medical devices / United States / Talladium, Inc.
Talladium, Inc.: FDA-registered device maker in Santa Clarita, CA, United States, 7 510(k) clearances
Talladium, Inc. is registered with the FDA (registration 2023129) in Santa Clarita, CA, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 15, 2016. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2023129
- Address
- 27360 West Muirfield LN., Santa Clarita, CA, United States, 91355
- Owner or operator
- TALLADIUM, INC. (2023129)
- Roles
- Manufacturer
- First device listed
- January 16, 2007
- Registered through
- 2026
- Brand names listed
- Hi-Tech Pre-Solder, Laser Welding wire, Luminesse Acetal, Luminesse Anterior Zirconia AT, Luminesse Chrome-Cobalt Discs, Luminesse Multilayer Anterior Zirconia AT, Luminesse One For All ZR, Luminesse One for All ZR ML and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2016 | K152023 | Luminesse Shaded Zirconia SZ | EIH | Substantially Equivalent | Talladium, Inc. | accessdata.fda.gov |
| October 21, 2015 | K152066 | Luminesse Anterior Zirconia AT | EIH | Substantially Equivalent | Talladium, Inc. | accessdata.fda.gov |
| June 15, 2015 | K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | EIH | Substantially Equivalent | Talladium, Inc. | accessdata.fda.gov |
| April 24, 2015 | K142371 | Luminesse PMMA | EBG | Substantially Equivalent | Talladium, Inc. | accessdata.fda.gov |
| December 17, 2014 | K140848 | LUMINESSE PORCELAIN SYSTEM | EIH | Substantially Equivalent | Talladium, Inc. | accessdata.fda.gov |
| May 21, 2010 | K100232 | LUMINESSE ZR BLANKS | EIH | Substantially Equivalent | Talladium, Inc. | accessdata.fda.gov |
| December 20, 1989 | K894085 | TALLADIUM TILITE CERAMIC ALLOY | EJH | Substantially Equivalent | Talladium, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2020 | 86614 | Class III | Terminated | Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a denta | Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtur | accessdata.fda.gov |
| August 6, 2020 | 86227 | Class II | Terminated | Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dent | The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range. | accessdata.fda.gov |
Compare with other makers
- All makers of Alloy, Metal, Base
- All makers of Powder, Porcelain
- All makers of Crown And Bridge, Temporary, Resin
Updated September 15, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.